Articles

Parenteral drugs are becoming increasingly complex,
creating new challenges and opportunities. This paper explores potential innovations across the entire value chain.

Innovations in Parenteral Medicines Packaging

Despite selecting the right, compendial excipients for a balanced formulation, you may encounter obstacles that delay market deadlines. Learn how to streamline the formulation and fill-finish process with the right raw material selection, secure and efficient fluid pathway design, comprehensive regulatory support, and supply chain transparency. 

Key Drivers to Overcome Obstacles in mAbs Formulation and Fill-Finish

Biopharma companies often lack the capacity and infrastructure to handle large buffer volumes needed for mAb production. Avantor offers four key strategies to improve operational efficiencies and reduce facility footprint, such as pre-weighed, GMP-compliant raw materials or ready-to-use hydrated solutions. Learn more about these customizable solutions.

Integrated buffer prep solutions

The growing complexity of therapeutic monoclonal antibodies (mAbs),
especially bispecific antibodies, presents significant manufacturing challenges such as
instability, low yields and aggregation. This article explores innovative solutions,
including detergent-based viral inactivation as an alternative to low pH treatment, high-
performance chromatography ligands and advanced formulation excipients.

Adopting novel technologies to improve monoclonal antibody processes

Scaling up monoclonal antibody (mAb) production can be challenging, but it doesn't have to slow you down. Explore how our large-volume handling solutions, GMP-grade chemicals and customized solutions for process development, optimization, and validation help you scale up quickly and meet regulatory standards with confidence.  

mAbs Scale-up video

Can biopharma manufacturers avoid extra costs, potential problems and wasted production time by designing a fully compliant (cGMP) manufacturing process early on? This article explores where planning ahead, using compendial raw materials of the highest quality and purity, can yield substantial benefits to both productivity and patient safety. 

The rewards of planning ahead: designing for full GMP production at pilot scale

In the wake of the Food and Drug Administration's (FDA's) latest guidance on nitrosamine contamination, ensuring compliance and safeguarding pharmaceutical products is more critical than ever. This ebook provides a comprehensive roadmap for understanding nitrosamine risks and offers actionable strategies to mitigate potential impurities. Through expert insights from Adare Pharma Solutions, you’ll learn how to remain compliant, identify risks, and implement cutting-edge strategies for nitrosamine mitigation.

Nitrosamine Mitigation: A Path to Regulatory Compliance

Looking to improve drug product effectiveness and differentiate? Mucoadhesion – the ability of a formulation to adhere to a mucous membrane – is an attractive option for those keen to ensure their products stand out in a crowded market.

Mucoadhesion Guide

Carbopol® polymers are efficient suspending agents that simplify manufacturing and improve the dosing experience for pediatric and geriatric patients. They offer excellent performance and versatility as pharmaceutical suspending agents for oral liquid formulations. They are compatible with various APIs, flavors, and preservatives and also provide a reliable supply. In this webinar, the Lubrizol team together with the IMCD team takes you through formulation aspects of Carbopol® polymers as well as the results of a case study on an Acetaminophen oral suspension formulation.

Advantages of Carbopol ® Polymers as suspending agents for oral liquid formulations

This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of pharmaceutical applications will also be reviewed, also how it can improve and differentiate drug products.

All Whitepapers